| Date Initiated by Firm | October 16, 2018 |
|---|
| Create Date | January 12, 2019 |
|---|
| Recall Status1 |
Terminated 3 on June 29, 2020 |
| Recall Number | Z-0731-2019 |
|---|
| Recall Event ID |
81723 |
| 510(K)Number | K162719 |
|---|
| Product Classification |
Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
|
| Product | iTotal Hip Replacement System, Total Hip Replacement System, Catalog Number HAA-050-D001-020101 |
|---|
| Code Information |
Serial Number 0424647 |
Recalling Firm/
Manufacturer |
Conformis, Inc.
600 Technology Park Dr
Billerica MA 01821-4154
|
| For Additional Information Contact | Tom Haueter
781-345-9161 |
|---|
Manufacturer Reason
for Recall | The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm. |
|---|
FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | The customer was contacted via email on 10/16/18. |
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| Quantity in Commerce | 1 |
|---|
| Distribution | The products were distributed to the following US states: TN. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
| 510(K) Database | 510(K)s with Product Code = LPH
|
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